Serum/plasma micronas and uses thereof

Abstract

This invention provides a combination of microRNAs for evaluating the physiological and / or pathological condition of a subject, wherein the combination comprises all detectable microRNAs stably existing in the serum / plasma of a subject; and a method for evaluating the physiological and / or pathological condition of a subject, wherein the method includes determining all detectable microRNAs stably existing in the serum / plasma of a subject; and a kit for evaluating the physiological and / or pathological condition of a subject, wherein the kit contains the tools for determining all detectable microRNAs that stably existing in the serum / plasma of a subject; and a biochip for evaluating the physiological and / or pathological condition of a subject, wherein the biochip contains the components for determining all detectable microRNAs stably existing in the serum / plasma of a subject. The aforementioned combination, method, kit and biochip can be used for diagnosis as well as differentially diagnosis of diseases including various tumors; various acute / chronic infectious diseases, e.g. viral diseases such as viral influenza, viral hepatitis, AIDS, SARS, bacterial diseases such as tuberculosis, bacterial pneumonia, and other acute / chronic infectious diseases caused by various pathogenic microorganisms; other acute / chronic diseases such as diseases of respiratory system, diseases of immune system, diseases of blood and hematopoietic system, diseases of circulatory system such as cardio-cerebrovascular diseases, metabolic diseases of endocrine system, diseases of digestive system, diseases of nervous system, diseases of urinary system, diseases of reproductive system and diseases of locomotor system, prediction of complications occurrence and malignant diseases relapse, evaluation of therapeutic effects, screening of pharmaceutical active ingredients, assessment of drug efficacy as well as forensic authentication and prohibited drug inspection and the like, possessing a number of advantages such as extensive detection spectrum, high sensitivity, low cost, convenience for sampling, ease for sample preservation, etc. The said method can be widely used in work related to general survey of diseases and so on, improve the low-specificity and low-sensitivity caused by individual differences which single markers are difficult to overcome, significantly increasing the clinical detection rate of diseases, all of which make it become an effective means for diagnosing diseases in an early phase.

Description

TECHNICAL FIELD[0001]The present invention relates to microRNAs and uses thereof, more specifically, to serum / plasma microRNAs and the uses of serum / plasma microRNAs for diagnosis and differential diagnosis of diseases, prediction of complication occurrence and malignant disease relapse, evaluation of therapeutic effects, screening of pharmaceutical active ingredients, assessment of drug efficacy, forensic authentication and prohibited drug inspection and the like.BACKGROUND ART[0002]To locate and precisely detect disease markers has already been the important precondition for the diagnosis and treatment of various clinical diseases including various tumors; various acute / chronic infectious diseases, e.g. viral diseases such as viral influenza, viral hepatitis, AIDS, SARS, bacterial diseases such as tuberculosis, bacterial pneumonia, and other acute / chronic infectious diseases caused by various pathogenic microorganisms; other acute / chronic diseases such as diseases of respiratory s...

AI Technical Summary

Benefits of technology

[0039](1) As novel disease markers, serum / plasma microRNAs possess certain advantages such as extensive spectrum for detection, high sensitivity, low cost for detection, convenient sampling, easy preservation for samples (preserving serum / plasma at −20° C. will do), etc. This method can be widely used in general survey of diseases and other relevant tasks and has become an efficient means for early diagnosis of diseases.

[0040](2) As novel disease markers, serum / plasma microRNAs will improve the low-specificity and low-sensitivity caused by individual differences which single markers are difficult to overcome, and notably increase the clinical detection rate of diseases so as to realize early diagnosis of diseases.

Problems solved by technology

Although more and more disease markers have been found and utilized in general survey and diagnosis of clinical diseases as well as monitoring and controlling of therapeutic effects, their clinical application effects are obviously insufficient.

But these disease markers are far from meeting the needs of early diagnosis for cancer for the following two main reasons: (1) the sensitivity and specificity for the above-mentioned disease markers are relatively low, thus their detection results cannot be used as a diagnostic indicator of disease; (2) the early diagnosis rate of disease shall be positively correlative with the therapeutic effects.

However, it is difficult for any of the aforesaid disease markers to meet such requirements for early diagnosis.

Take cancer for example, the specificity of tumor differentiation is too high, the integrated sensitivity of tumor is relatively low, the samples sent to be detected are difficult to be repeatedly taken and the conditions to meet the preservation requirements for samples are too exacting, meanwhile, the cost is very high, thus under existing technology the spreading and use of the tumor markers available are hard to realize.

The inherent defects of some traditional medical means such as biopsy, for example, incorrect material-extraction position, the inadequacy of sample materials for histocytes and human inexperience, etc., will all lead to misdiagnosis.

Although other techniques such as imaging technique have been widely used for examination and diagnosis of diseases, there exists considerable limitation on the determination for disease degree.

First of all, the changes of microRNAs may be the cause of diseases.

Secondly, the changes of microRNAs may also result from diseases.

However, since the sampling for tissue specimen is not easy, the wide application of this method in clinics is limited.

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